K Number
K241632
Device Name
Electrically powered wheelchair
Date Cleared
2024-10-16

(132 days)

Product Code
Regulation Number
890.3860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement. The DC Brushless motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.
More Information

No
The description focuses on mechanical and electrical components (motor, battery, controller, frame, wheels) and user control via a joystick. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.

No
The device is a transportation vehicle designed to provide mobility for disabled or elderly individuals, not to treat or cure a medical condition.

No

Explanation: The device is described as a motor-driven transportation vehicle designed to provide mobility for disabled or elderly individuals, indicating it is an assistive device rather than a diagnostic one. Its function is to move a person, not to diagnose a medical condition.

No

The device description clearly outlines multiple hardware components including a frame, wheels, seat, armrest, lithium battery, motor, and controller. It is a physical transportation vehicle.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to provide mobility to a disabled or elderly person. This is a physical function, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description details a mechanical and electrical device for transportation. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
  • Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling, or any other typical features of an in vitro diagnostic device.

In summary, this device is a power wheelchair, which is a medical device used for mobility assistance, not for diagnosing diseases or conditions through the analysis of biological samples.

N/A

Intended Use / Indications for Use

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Product codes

ITI

Device Description

This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device.

The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.

When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement.

The DC Brushiess motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K231508.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K231508

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

October 16, 2024

Kunshan Hi-Fortune Health Products Co., Ltd % Ariel Xiang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China

Re: K241632

Trade/Device Name: Electrically powered wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: September 16, 2024 Received: September 16, 2024

Dear Ariel Xiang:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241632

Device Name

Electrically powered wheelchair

Indications for Use (Describe)

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) #: K241632510(k) SummaryPrepared on: 2024-09-16
Contact Details21 CFR 807.92(a)(1)
Applicant NameKunshan Hi-Fortune Health Products Co., Ltd
Applicant AddressNO.625 Juxiang Road, Zhangpu Town kunshan, Jiangsu, 215321 China
Applicant Contact Telephone+86 13771986496
Applicant ContactMr. Zhanli Tian
Applicant Contact Emailzhanli.tian@hi-fortune.net
Correspondent NameShanghai Sungo Management Consulting Co. Ltd.
Correspondent Address14th Floor, 1500# Century Avenue shanghai shanghai 200122 China
Correspondent Contact Telephone+86-21-58817802
Correspondent ContactMs. Ariel Xiang
Correspondent Contact Emailshouqiu.xiang@sungoglobal.com
Device Name21 CFR 807.92(a)(2)
Device Trade NameElectrically powered wheelchair
Common NamePowered wheelchair
Classification NameWheelchair, Powered
Regulation Number890.3860
Product Code(s)ITI
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #Predicate Trade Name (Primary Predicate is listed first)Product Code
K231508Power wheelchair, W5521ITI
Device Description Summary21 CFR 807.92(a)(4)

This product consists of frame, wheels, seat, armrest, ithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device.

The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.

When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement.

5

The DC Brushiess motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.

Intended Use/Indications for Use

It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Indications for Use Comparison

Same.

Technological Comparison

The subject device complied with the requirements of ISO 7176-2:2001, ISO 7176-3:2012, ISO 7176-4:2008, ISO 7176-5:2008. ISO 7176-6:2018. ISO 7176-7:1998. ISO 7176-9:2009. ISO 7176-10:2008. ISO 7176-11:2008. ISO7176-13:1989, ISO 7176-14:2008, ISO 7176-15:1996, ISO 16840-10: 2021, ISO7176-21:2014, ISO 7176-22:2013, IEC 60601-1-2: 2014, IEC 62133-2:2017.

The intended uses for both devices are the same. Mainframes of two devices are folded by way of front and rear close.

The design principles of the controller and Driving system are the requirements of the ISO 7176-14.2008. Software validation is carried out on both control systems and speed control are designed in the same way as well, and both meet the requirements of the ISO 7176-3:2012.

Turning radius and Maximum obstacle climbing are sightly different while such differences will not impact the safety and effectiveness of the subject device or raise new safety and effectiveness concerns as well as both meet the ISO 7176-22001, ISO 7176-10:2008.

The flame retardant test of the seat cushion/backrest of the subject device is conducted according to ISO 16840-10. Therefore, both devices are assured to be under the same safety level.

The all rest different between the subject device can proved the safety or effectiveness by the ISO 7176 series support reports.

Different material used for parts in contact with user, which such differences will not impact the subject device as biocompatibility tests are carried out according to ISO 10993 series.

In conclusion, the technological characteristics, features, materials, mode of operation, and intended use of the device substantially equivalent to the predicate devices quoted above. The differences between the subject devices do not raise new issues of safety or effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Not Applicable

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K231508.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)